BioMedomics, Morrisville, NC, is now able to distribute its Covid-19 IgM-IgG Antibody rapid test to any licensed healthcare practitioner in the United States for diagnostic use. The move follows a March 16 update to FDA’s Immediately in Effect Guidance for Clinical Laboratories, Commercial Manufacturers, and Food and Drug Administration Staff: Policy for Diagnostic Tests for Coronavirus Disease-2019 during the Public Health Emergency.
BioMedomics’ Covid-19 IgM/IgG Antibody rapid test is one of the world’s first rapid point-of-care lateral-flow immunoassays for the diagnosis of coronavirus infection. The test has been used widely by the Chinese to combat infections, and is now available globally. The test detects both early-marker and late-marker IgM/IgG antibodies in human fingerstick (capillary) or venous whole blood, serum, and plasma samples.
The test can be used for rapid screening of carriers of the virus who may be either symptomatic or asymptomatic. Recent studies suggest that a high percentage of patients show no clinical symptoms of the virus; thus screening is vitally important. The test is suited for hospitals, clinics, and test laboratories. The test can also be effectively deployed in businesses, schools, airports, seaports, train stations, and elsewhere.
The test works in 15 minutes, and features an intuitive visual interpretation. No special equipment is needed.
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